MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that subject coil comes off itself in the catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual / microscopic inspection indicated that the main coil was returned detached from the delivery wire.The second device returned had the main coil attached to the delivery wire, therefore this is not the subject device.The returned main coil was kinked in a number of locations.Functional test: not required as the defect was visually confirmed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It was reported that the coil comes off by itself in the catheter.The device was returned for analysis and the main coil was noted to have been prematurely detached and the main coil was kinked, confirming the reported event.There was no answer received to the additional questions.It is probable that the device was damaged due to anatomical or procedural factors during use of the device.An assignable cause of procedural factors will be assigned to the reported and analyzed main coil prematurely detached/separated during use and the analyzed main coil kinked/bent, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that subject coil comes off itself in the catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 3MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11586725
• Report Number: 3008881809-2021-00146
• Device Sequence Number: 4182892
• Product Code: HCG
• UDI-Device Identifier: 07613252600336
• UDI-Public: 07613252600336
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2022
• Device Model Number: M0035443040
• Device Catalogue Number: M0035443040
• Device Lot Number: 21974272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 MICRO CATHETER (STRYKER)
• Patient Age: 76 YR
• Patient Weight: 95